Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
YF-17D · 1 trial · 1 indication
Seroprotection was defined as reciprocal anti-YF neutralizing antibody titer ≥10. Immunological naivety to YF and DENV was defined as Baseline reciprocal neutralizing antibody titers \<10 for YF and for the 4 dengue serotypes. The 95% CI was calculated using exact Clopper-Pearson method.
| Arm | Type | Description |
|---|---|---|
| Group 1: YF-17D + Placebo/TDV/TDV | EXPERIMENTAL | YF-17D vaccine, 0.5 mL injection, subcutaneously (SC) plus YF 17D + TDV placebo-matching 0.5 mL, injection, SC on Day 1, followed by TDV, 0.5 mL, injection, SC on Day 90 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 180 (second dose). |
| Group 2: TDV + Placebo/TDV/YF-17D | EXPERIMENTAL | TDV, 0.5 mL, injection, SC plus TDV placebo-matching, 0.5 mL injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 90 (second dose), followed by YF-17D vaccine, 0.5 mL, injection, SC on Day 180. |
| Group 3: TDV + YF-17D/TDV/Placebo | EXPERIMENTAL | TDV, 0.5 mL, injection, SC plus YF-17D vaccine, 0.5 mL, injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on day 90 (second dose), followed by TDV + YF 17D placebo-matching, 0.5 mL, injection, SC on Day 180. |
| Name | Type | Description |
|---|---|---|
| YF-17D | BIOLOGICAL | YF-17D SC injection. |
| TDV | BIOLOGICAL | TDV SC injection. |
| Placebo | DRUG | Normal Saline (0.9% NaCl) SC injection. |
Inclusion Criteria: 1. Is aged 18 to 60 years inclusive, at the time of randomization. 2. Is in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs), and the clinical judgment of the Investigator. Exclusion Criteria: 1. Has...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 5 | PHASE3 | Tetravalent Dengue Vaccine |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE2 | EYU688 |
| Sanofi SA Sponsored ADR | SNY | 1 | - | Undisclosed |
| Abbott Laboratories | ABT | 1 | - | Undisclosed |
| Danaher Corporation | DHR | 1 | - | Undisclosed |
YF-17D is a monoclonal antibody being developed for dengue, a mosquito-borne viral infection. It is currently in Phase 3 clinical development as an investigational therapy. The drug is being studied for its potential to address dengue, though it has not yet been approved for use.
YF-17D is being developed by Takeda Pharmaceutical Company Limited, a global biopharmaceutical company. Takeda's stock is traded under the ticker symbol TAK. The company is conducting clinical trials to evaluate the safety and efficacy of YF-17D for dengue.
YF-17D is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial is designed to assess the immunogenicity and safety of the drug when administered with a yellow fever vaccine in adults.
YF-17D has one completed Phase 3 clinical trial registered under NCT03342898. The trial, titled "Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) Administered With a Yellow Fever Vaccine in Adults," enrolled 900 participants in the United States. The study was controlled and randomized, though not double-blind.
YF-17D is a monoclonal antibody, not a vaccine. It is being studied for dengue, but it is distinct from the tetravalent dengue vaccine (TDV) mentioned in the clinical trial title. The trial evaluated the co-administration of YF-17D with a yellow fever vaccine, but YF-17D itself is an antibody therapy.